To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com. Thank you!

Pay Range: $27 to $32 per hour

Client Industry: Pharmaceutical

Work Type: Onsite

Duration: 9 Months Contract with possibilities of extension

Job Summary:

We are seeking a highly motivated Microbiology and Cleaning Validation Associate to support Manufacturing Sciences and Technology activities within a regulated pharmaceutical manufacturing environment. This opportunity is ideal for a recent Master’s graduate with strong microbiology fundamentals and an interest in contamination control, cleaning validation, and GMP operations. The role offers hands on experience supporting sampling activities, validation programs, risk assessments, investigations, and inspection readiness initiatives. The successful candidate will work closely with Quality, Manufacturing, Engineering, and laboratory teams while ensuring compliance with quality and data integrity standards. This position provides valuable exposure to microbiological control strategies and lifecycle process support in a pharmaceutical setting.

Key Responsibilities:

• Perform microbiological and cleaning validation sampling activities including swab and rinse sample collection.
• Create and execute protocols for routine cleaning verification and TOC sampling activities.
• Apply aseptic and low bioburden handling practices during sampling and validation activities.
• Support TOC based cleaning validation through sample handling, data review, and laboratory coordination.
• Assist with microbial and chemical cleanliness risk assessments for equipment and manufacturing processes.
• Document sampling activities, observations, and results in accordance with GMP and ALCOA+ data integrity requirements.
• Support validation, PPQ, and process verification activities related to new product introductions and equipment modifications.
• Participate in deviation investigations and CAPA activities associated with microbiological or cleaning events.
• Collaborate with cross functional teams including MS&T, QA, QC, Engineering, and Manufacturing.
• Support validation campaigns that may require off shift or weekend activities.

Required Qualifications:

• Master’s degree in Microbiology, Biology, Biotechnology, or a related scientific discipline.
• Recent Master’s graduate with strong microbiology fundamentals.
• Foundational understanding of microbiology principles and contamination control practices.
• Knowledge of aseptic and low bioburden handling techniques.
• Awareness of swab and rinse sampling techniques including environmental monitoring.
• Understanding of TOC principles and applications in cleaning verification.
• Strong documentation skills with a focus on quality and data integrity.
• Digital literacy with exposure to basic AI concepts and their application in daily work.
• Ability to work in manufacturing and controlled environments and perform physical sampling activities including use of ladders and lifts.

Preferred Qualifications:

• Internship, academic research, or cooperative education experience in microbiology or GMP environments.
• Exposure to pharmaceutical manufacturing, validation, quality systems, or laboratory operations.
• Familiarity with rapid analytical techniques.
• Experience supporting investigations, risk assessments, or validation documentation.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)